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Not yet recruiting NCT07271914

PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

No phase Interventional Early Stage Ovarian Tumors Peritoneal Carcinosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach, Histopathologic Analysis.
Who it may be relevant to
Registry conditions: Early Stage Ovarian Tumors, Peritoneal Carcinosis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study

Overview

Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens

Detailed description

The study focuses on the excision of anatomically defined pelvic peritoneal areas, with meticulous dissection of the retroperitoneal spaces and a nerve-sparing approach. Combined with a specific pathology protocol, this strategy improves the detection of microscopic peritoneal involvement and provides new insights into the mechanisms of pelvic recurrence

Interventions

  • Procedure systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach
    Surgical Procedure: Initial step: Exclude upper abdominal disease through inspection and guideline-based biopsies. Pelvic peritoneal resection: En bloc or segmental removal of predefined pelvic peritoneal regions according to dissection of retroperitoneal spaces with a nerve-sparing technique.
  • Diagnostic test Histopathologic Analysis
    Fixation: 10% neutral-buffered formalin for 6-48 hours. Processing: Paraffin eembedding and complete sampling for histology. Staining: H\&E and immunohistochemistry (MOC-31, BER-EP4) to identify epithelial tumor cells. Reporting: Checklist for peritoneal disease

Primary outcome measures

  • Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants). [Time frame: from surgery up to at least 24 months of follow up after surgery]
Secondary outcome measures (4)
  • Perioperative complications [Time frame: from the date of surgery up to six months after surgery]
  • Recurrence site [Time frame: from the date of surgery up to at least 24 months of follow up]
  • 2-year progression free survival [Time frame: 24 months after surgery]
  • 2-year overall survival [Time frame: 24 months after surgery]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors
  • Complete preoperative work-up (ultrasound, CT scan, tumor markers)
  • Laparoscopic, robotic or open surgical approach
  • Signed informed consent

Exclusion criteria

  • Sarcomas, melanomas, mesotheliomas, hematologic malignancies
  • Advanced ovarian tumors
  • Fertility-sparing surgery with uterine preservation
  • Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • Azienda Ospedaliera Santa Croce e Carle Cuneo — Cuneo

Publications

  • van de Vorst REWM, Hoogendam JP, van der Aa MA, Witteveen PO, Zweemer RP, Gerestein CG. The attributive value of comprehensive surgical staging in clinically early-stage epithelial ovarian carcinoma: A systematic review and meta-analysis. Gynecol Oncol. 2021 Jun;161(3):876-883. doi: 10.1016/j.ygyno.2021.04.007. Epub 2021 Apr 10. PMID 33849726

Identifiers

NCT: NCT07271914 · CnGin20251

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗